BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 9269286 · Received November 1, 2019

    Report

    Report Number
    2024168-2019-13122
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648226342
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED CLIP OPENING WHILE ESTABLISHING FINAL ARM ANGLE (EFAA) WAS NOT CONFIRMED DURING RETURN DEVICE ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A DEFINITIVE CAUSE FOR THE REPORTED CLIP OPENING DURING EFAA COULD NOT BE DETERMINED IN THIS INCIDENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE TWO OTHER MITRACLIP NTR DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE CLIP FAILED TO ESTABLISH FINAL ARM ANGLE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR), WITH AN MR GRADE OF 3-4. THE CLIP DELIVERY SYSTEM (CDS) (90417U186) WAS ADVANCED TO THE MITRAL VALVE. CLIP DEPLOYMENT WAS STARTED; HOWEVER, THE LOCK LINE COULD NOT BE REMOVED. THE CLIP WAS NOT DEPLOYED. THE CLIP WOULD NO LONGER CLOSE, AND HAD TO BE INVERTED, THUS WAS DIFFICULT TO REMOVE FROM THE STEERABLE GUIDE CATHETER (SGC). THE CDS AND SGC WERE REMOVED AS A SINGLE UNIT. A NEW SGG WAS USED AND CDS (90412U378) WAS ADVANCED, BUT FINAL ARM ANGLE (EFAA) COULD NOT BE ESTABLISHED, CLIP OPENED WHILE LOCKED. THE CLIP WAS NOT IMPLANTED AND WAS REMOVED. ANOTHER CDS (90418U226) WAS ADVANCED; AGAIN EFAA COULD NOT BE ESTABLISHED. THE CLIP WAS NOT IMPLANTED AND WAS REPLACED. ONE CLIP WAS IMPLANTED, REDUCING MR TO <1. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060169 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR 90412U378 08717648226342

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR STEERABLE GUIDE CATHETER